Seal element for anastomosis

ABSTRACT

A seal element for sealing between tissue lumens includes a first material for allowing tissue ingrowth and a second sealant material.

CROSS-REFERENCE TO RELATED APPLICATION

The present application claims the benefit of and priority to U.S.Provisional Application Ser. No. 60/619,238, filed on Oct. 15, 2004, theentire disclosure of which is incorporated herein by reference.

BACKGROUND

1. Technical Field

The present disclosure relates to devices for attaching two tubulartissues. More particularly, seals for use in connection with anastomosisprocedures are described.

2. Background of Related Art

One method for performing a gastrointestinal anastomosis involves theuse of a circular stapler apparatus. For example, a device known as theCEEA® (trademark of United States Surgical, a division of TycoHealthcare Group LP) is utilized after resection of a diseased portionof bowel. The circular anastomosis stapler is utilized to approximatethe remaining portions of bowel, staple them together, and cut awayexcess tissue at the anastomotic joint.

Illustrative circular stapling devices are disclosed in certainembodiments of U.S. patent application Ser. Nos. 4,354,628; 5,014,899;5,040,715; and 5,392,979 the disclosures of which are herebyincorporated herein in their entirety by this reference. Other methodsof performing anastomoses, utilizing joining techniques other thanstapling that have been contemplated include, for example the use ofclip appliers, dissectors and shears, and adhesives.

While present anastomosis devices and procedures perform satisfactorily,it would be advantageous to promote tissue growth and good sealing at ananastomosis site.

SUMMARY

A composite seal element for use in anastomosis is described herein. Theseal element can be disposed between the two portions of tubular tissueto be joined to promote tissue growth and reduce the occurrence ofleaks. In stapled anastomoses, the seal element is disposed between theproximal and distal ends of an anastomosis before the tissue isapproximated and staples are fired. The seal element remains in placeduring the healing process and then, in certain embodiments is absorbedby the body.

One aspect of the present disclosure is a seal element for sealingbetween tissue lumens, comprising a first material and a secondmaterial. The first material comprises a porous material for allowingtissue ingrowth. The second material comprises a sealant.

In embodiments, the second material comprises a compressible materialthat, when compressed between a first tissue lumen and a second tissuelumen, acts as a seal to prevent the escape of the contents of thetissue lumens. Preferably, the first material and the second materialare biodegradable, bioabsorbable, or bioresorbable materials.

In certain embodiments, the seal element comprises an annular elementand the second material is disposed outwardly of the first material. Thefirst and second materials may be adhered to one another, with abiocompatible adhesive, or joined utilizing an overmolding process.

Another aspect of the present disclosure is an assembly for disposing aseal element between tissue lumens comprising a circular surgicalstapling device, having an anvil assembly and a tubular body portion,the anvil assembly having an anvil member and a first shaft, the tubularbody portion carrying a plurality of surgical staples in a circularconfiguration, the tubular body portion having a second shaft disposedinwardly of the surgical staples, the first shaft being attachable tothe second shaft. The assembly includes a seal element comprising afirst material and a second material. The first material comprises aporous material for allowing tissue ingrowth. The second materialcomprises a sealant.

Preferably, the second material comprises a compressible material that,when compressed between a first tissue lumen and a second tissue lumen,acts as a seal to prevent the escape of the contents of the tissuelumens. Preferably, the first material and the second material arebiodegradable, bioabsorbable, or bioresorbable materials.

The seal element desirably has a generally centrally located aperturefor being disposed on one of the first shaft and the second shaft of thecircular surgical stapling device.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate embodiments of the disclosureand, together with a general description of the disclosure given aboveand the detailed description of the embodiments given below, serve toexplain the principles of the disclosure, wherein:

FIG. 1 is a perspective view of a seal element in accordance with anembodiment of the present disclosure, shown in an undeployed condition;

FIG. 2 is a perspective view of an exemplary annular surgical staplingdevice;

FIG. 3 is a longitudinal, partially cross-sectional view illustratingthe anvil rod mounted to the annular stapling device within a surgicalsite and the seal element of FIG. 1 in an undeployed condition, disposedbetween the apposed surfaces of the tissue; and

FIG. 4 is a perspective, cross sectional view of the seal element ofFIG. 1 shown in a deployed condition.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

As shown in FIG. 1, a seal element 10 in accordance with the presentdisclosure can be a composite of a first material 12 and a secondmaterial 14, and includes a center aperture 15.

In certain embodiments, the first material 12 can be relatively thin(compared to the second material) and optionally is a bioabsorbablematerial that promotes tissue ingrowth. In certain preferredembodiments, first material 12 can be about 0.010″ to about 0.020″thick, although other thicknesses can be used. As those skilled in theart will appreciate, tissue ingrowth is promoted more readily bymaterials having pores formed therein. Thus, for example, first material12 can be any biocompatible, optionally bioabsorbable porous material,such as, for example, a foam, a mesh, a non-woven structure, or aperforated sheet. In certain preferred embodiments, first material 12has pores in the range of about 50 μm to about 200 μm. Illustrativeexamples of suitable bioabsorbable porous materials include anabsorbable hernia mesh such as Dexon, an absorbable felt such asPolysorb, or a porous open-cell foam such as polyurethane, suitablehomopolymers, glycolide, lactide, caprolactone, trimethylene carbonate,dioxanone, polyalkylene oxides, etc. Other suitable materials aredisclosed in certain embodiments of U.S. Pat. Nos. 4,655,221; 4,788,979;5,543,218; 5,716,376; 5,423,859; and 5,124,103, the disclosures of whichare hereby incorporated herein in their entirety by this reference.Without being limited to a particular theory of operation, there is aconsiderable amount of healing that takes place in this region.Therefore, this material is desirably porous enough to allow tissue togrow through it.

The second material 14 desirably forms a seal. Thus, second material 14can be, for example, either a compressible or expandable optionallybioabsorbable material. In use, compressible second materials 14, whencompressed, act as a seal to prevent the escape of fluid from theconnected tubular tissue. In some embodiments, second material 14 is asoft, compliant material that is compressed between the proximal 16 anddistal ends 18 of the anastomosis and captured by staples 33, 35. See,e.g., FIG. 4. The compression of this material can serve, for example,as a gasket to prevent bowel contents from leaking into the peritoneum.Illustrative examples of compressible materials include, but are notlimited to polyurethane foam, carboxymethyl cellulose (“CMC”), andhydrogels.

For expandable second materials 14, the material may expand in responseto contact with fluids, such as the fluids naturally present in thebody. In embodiments, second material 14 can be a de-hydrated materialthat swells upon contact with moisture. For example, second material 14can be a hydrophilic biomaterial. Illustrative examples of suitablehydrophilic biomaterials include, but are not limited to polymers formedfrom one or more of the following monomers: methacrylic acid, acrylicacid, n-vinyl pyrrolidone, potassium sulfopropyl acrylate, potassiumsulfopropyl methacrylate, acrylamide, dimethylacrylamide,2-methacryloyloxyethyl phosphorylcholine, 2-hydroxyethyl methacrylate orsimilar biocompatible water-soluble vinyl monomers. In a particularlyuseful embodiment, second material 14 is formed of poly(2-hydroxyethylmethacrylate). Where seal element 10 includes a hydrophilic biomaterialas second material 14, seal element 10 can be prepared using techniqueswithin the purview of those skilled in the art. For example, the sealelement can be formed by filling a mold with a composition containingthe monomer(s) and, if desired or necessary, initiator, crosslinker,plasticizer and/or biological agent, and polymerizing the compositionwithin the mold. The choice of particular initiators, crosslinkers, etc.will be determined by the specific choice of monomer(s) and can bereadily determined by those skilled in the art. A particularly usefulhydrophilic biomaterial is poly(2-hydroxyethyl methacrylate) (“PHEMA”).The equilibrium water content (EWC), swelling, and mechanical propertiesof the PHEMA portion of seal element 10 can be controlled by crosslinkdensity (e.g., the crosslink density can be controlled by radiationconditions or crosslinking agent, such as di(ethylene glycol)dimethacrylate (DEGDMA), concentration). The thickness of the sealelement 10 is controlled by the volume of the monomer compositionpolymerized in the mold. The PHEMA portion of seal element 10 can alsobe surface modified following formation. For example, the PHEMA portionof seal element 10 can be surface modified with polymeric phospholipidsfor improved hemocompatibility and tissue interaction using gammaradiation grafting.

In embodiments, the surface of the portion of the seal element made fromsecond material 14 can be patterned or templated in the nano-meso-microscale to accommodate preferential tissue interaction at the tissue/sealinterface. Such architecture or patterns can prevent or minimizepost-operative tissue adhesions and superfluous collagen deposition, butafford desired mechanical and biophysical support for wound healing.

Either or both of first material 12 and second material 14 from whichseal element 10 is made may also contain one or more medically and/orsurgically useful substances such as drugs, enzymes, growth factors,peptides, proteins, dyes, diagnostic agents or hemostasis agents or anyother pharmaceutical used in the prevention of stenosis. Non-limitingexamples of suitable medically and/or surgically useful substancesinclude: antimicrobials, antibiotics, anti-fungals, anti-virals,monoclonal antibodies, polyclonal antibodies, antimicrobialproteins/peptides (whole and fragments), enzymes, gene therapy, viralparticles, chemotherapeutics, anti-inflammatories, NSAIDS, steroids,telomerase inhibitors, growth factors (TGF family, interleukinsuperfamily, fibroblast derived GFs, macrophage derived GFs, etc.),extracellular matrix molecules (laminin, thrombospondin, collagen,fibronectin, synthetic ECM, etc.), cell adhesion molecules,polysaccharides (hyaluronic acid, carboxymethyl cellulose, alginate,sulfonated dextran, heparin sulfate, chitosan, etc.) and others. Theseagents can be incorporated in situ into either or both of first material12 and second material 14 from which seal element 10 is made or postloaded onto seal element 10 using techniques within the purview of thoseskilled in the art. For example, the medically and/or surgically usefulsubstances can be freely mixed or loaded, electronically or ionicallybound, covalently immobilized, chelated, or encapsulated in particles,micelles, aggregates, or any nano-meso-micro solids of varied dimension,shape morphology and dispersion/suspension ability.

Second material 14 can be attached to first material 12 in any mannerwithin the purview of those skilled in the art, including, but notlimited to an overmolding process.

Seal element 10 desirably has a generally centrally located aperture 15for being disposed on one of the first shaft and the second shaft of acircular surgical stapling device. The seal element is captured betweenthe proximal and distal ends of a circular, stapled anastomosis toreduce leaks at the site of anastomosis.

The dimensions of seal element 10 may vary, according to the particularapplication. In certain embodiments, the outside diameter is slightlylarger than the diameter of the outside staple row of the circularstapling apparatus. The inside diameter will be slightly larger than thediameter of the knife of the circular stapling apparatus. Preferably,the inside diameter may be about the size of shaft 38 of anvil assembly40 in order to center seal element 10 on the anvil assembly 40.

Referring now to FIG. 2, an annular surgical stapling device, for usewith the annular structures disclosed herein, is generally designated as20. Surgical stapling device includes a handle assembly 22 having atleast one pivotable actuating handle member 24, and an advancing member26. Extending from handle member 22, there is provided a tubular bodyportion 30 which may be constructed so as to have a curved shape alongits length. Body portion 30 terminates in a staple cartridge assembly 32which includes a pair of annular arrays of staple receiving slots 46having a staple (not shown) disposed in each one of staple receivingslots 46. Positioned distally of staple cartridge assembly 32 there isprovided an anvil assembly 40 including an anvil member 36 and a shaft38 operatively associated therewith for removably connecting anvilassembly 40 to a distal end portion of the stapling device.

Staple cartridge assembly 32 may be fixedly connected to the distal endof tubular body portion 30 or may be configured to concentrically fitwithin the distal end of tubular body portion 30. Typically, staplecartridge assembly 32 includes a staple pusher (not shown) including aproximal portion having a generally frusto-conical shape and a distalportion defining two concentric rings of peripherally spaced fingers(not shown), each one of which is received within a respective staplereceiving slot 46.

Typically, a knife (not shown), substantially in the form of an open cupwith the rim thereof defining a knife edge, is disposed within staplecartridge assembly 32 and mounted to a distal surface of a staple pusher(not shown). The knife edge is disposed radially inward of the pair ofannular arrays of staples. Accordingly, in use, as the staple pusher isadvanced, the knife is also advanced axially outward.

Reference may be made to U.S. Pat. No. 5,915,616 to Viola et al., theentire content of which is incorporated herein by reference, for adetailed discussion of a suitable annular stapling device. Although thestapling device shown in FIGS. 2-3 is a circular stapling device, theseal element disclosed herein may be used with staplers of other shapesor configurations, such as, for example, linear staplers or annularstaplers that are not circular. In addition, the seal element may beplaced using sutures, adhesives, etc.

Turning now to FIG. 3, there is illustrated the use of surgical staplingdevice 20 and detachable anvil assembly 40 in an anastomosis procedureto effect joining of intestinal sections 66 and 68. At the point in theprocedure shown in FIG. 3, a diseased intestinal section has beenpreviously removed, anvil assembly 40 has been applied to the operativesite either through a surgical incision or transanally and positionedwithin intestinal section 66, and tubular body portion 30 of thesurgical stapling device has been inserted transanally into intestinalsection 68. Intestinal sections 66 and 68 are also shown temporarilysecured about their respective components (e.g., shaft 38 of anvilassembly 40, and the distal end of tubular body portion 30) byconventional means such as a purse string suture “P”.

According to one method, as seen in FIG. 3, if desired or if thesurgical procedure requires, seal element 10 may be placed onto shaft 38of anvil assembly 40 prior to the coupling of anvil assembly 40 to thedistal end of tubular body portion 30. Following positioning of sealelement 10 onto shaft 38 of anvil assembly 40, the surgeon maneuversanvil assembly 40 until the proximal end of shaft 38 is inserted intothe distal end of tubular body portion 30 of surgical stapling device20, wherein the mounting structure (not shown) within the distal end oftubular body portion 30 engages shaft 38 to effect the mounting.Thereafter, anvil assembly 40 and tubular body portion 30 areapproximated to approximate intestinal sections 66, 68 and capture sealelement 10 therebetween. The surgical stapling device 20 is then firedthereby stapling intestinal sections 66, 68 to one another and cuttingthe portion of tissue and seal element 10 disposed radially inward ofthe knife, to complete the anastomosis.

As seen in FIG. 4, the seal forming second material 14 is compressedbetween the proximal 16 and distal ends 18 of the anastomosis andcaptured by the staples 33, 35. The compression of this material servesas a gasket to prevent bowel contents from leaking into the peritoneum.The portion of seal element 10 made from first material 12 is exposed atthe site of anastomosis and serves to promote tissue ingrowth andthereby assist in healing of the site.

While several particular forms of the seal elements have beenillustrated and described, it will also be apparent that variousmodifications can be made without departing from the spirit and scope ofthe present disclosure. For example, it is envisioned hat each of theseal elements described herein may be used with an annular surgicalanastomosing device, not including any staples for securing tissuetogether, which is capable of approximating, adhering and cuttingtissue. Thus, it should be understood that various changes in form,detail and application of the support structures of the presentdisclosure may be made without departing from the spirit and scope ofthe present disclosure.

1. An assembly for disposing a seal element between tissue lumenscomprising: a circular surgical stapling device comprising an anvilassembly and a tubular body portion wherein the anvil assembly comprisesan anvil member and a first shaft and the tubular body portion comprisesa plurality of surgical staples in a circular configuration and a secondshaft disposed inwardly of the surgical staples, the first shaft beingattachable to the second shaft; and a seal element disposable betweentissue lumens, the seal element comprising a first material and a secondmaterial wherein the first material promotes tissue ingrowth and thesecond material comprises a sealant.
 2. The assembly of claim 1 whereinthe first material is a porous material.
 3. The assembly of claim 2wherein the first material is selected from the group consisting of afoam, a mesh, a non-woven structure, a perforated sheet and combinationsthereof.
 4. The assembly of claim 2 wherein the first material isselected from the group consisting of glycolide, lactide, caprolactone,trimethylene carbonate, dioxanone, polyalkylene oxides, and combinationsthereof.
 5. The assembly of claim 2 wherein the first material comprisesa porous material having pores ranging in size from about 50 μm to about200 μm.
 6. The assembly of claim 2 wherein the first material has athickness ranging from about 0.010 inches to about 0.020 inches.
 7. Theassembly of claim 2 wherein the second material is compressible.
 8. Theassembly of claim 2 wherein the second material is expandable.
 9. Theassembly of claim 2 wherein the second material is a hydrophilicmaterial.
 10. The assembly of claim 2 wherein the second material isderived from a monomer selected from the group consisting of methacrylicacid, acrylic acid, n-vinyl pyrrolidone, potassium sulfopropyl acrylate,potassium sulfopropyl methacrylate, acrylamide, dimethylacrylamide,2-methacryloyloxyethyl phosphorylcholine, hydroxethylmethacrylate,2-hydroxyethyl methacrylate and combinations thereof.
 11. The assemblyof claim 2 wherein the second material is poly(2-hydroxyethylmethacrylate).
 12. The assembly of claim 2 wherein the second materialcomprises a surface having a pattern formed thereon.
 13. The assembly ofclaim 2 wherein at least one of the first or second materials furthercomprises at least one medically useful substance.
 14. The assembly ofclaim 13 wherein the at least one medically useful substance is selectedfrom the group consisting of drugs, enzymes, growth factors, peptides,proteins, dyes, diagnostic agents, hemostasis agents, antimicrobials,antibiotics, anti-fungals, anti-virals, monoclonal antibodies,polyclonal antibodies, antimicrobial proteins/peptides, enzymes, genetherapy, viral particles, chemotherapeutics, anti-inflammatories,NSAIDS, steroids, telomerase inhibitors, growth factors, extracellularmatrix molecules, cell adhesion molecules, polysaccharides andcombinations thereof.
 15. The assembly of claim 2 further comprising agenerally centrally located aperture.
 16. A method of disposing a sealelement between adjacent tubular tissues to be joined, the methodcomprising: providing a circular surgical anastomosis device, thecircular surgical anastomosis device including: an anvil assembly havingan anvil member and a first shaft; and a tubular body portion having anannular knife operatively disposed therein and a second shaft disposedradially inward of the annular knife, the first shaft of the anvilassembly being selectively attachable to the second shaft of the tubularbody; inserting the anvil assembly into a first tubular tissue;inserting the tubular body portion into a second tubular tissue;disposing the seal element between the first tubular tissue and thesecond tubular tissue, the seal element comprising a first material anda second material wherein the first material promotes tissue ingrowthand the second material comprises a sealant; approximating the anvilassembly and tubular body portion with one another so that an endportion of the first tubular tissue, the seal element, and an endportion of the second tubular tissue are disposed between the anvilmember and the tubular body portion, the seal element being disposedbetween the first tubular tissue and the second tubular tissue; firingthe surgical anastomosis device to sever the portions of the first andsecond tubular tissues disposed radially inward of the annular knife,and to touch the portions of the first and second tubular tissuesradially outward of the annular knife against the seal element tothereby secure the seal element between the first and second tubulartissues.